Agilent Technologies 280-DS MQS User manual

Agilent Technologies
280-DS MQS
Operator’s Manual

280-DS Operator’s Manual
Notices
© Agilent Technologies, Inc. 2013
No part of this manual may be reproduced
in any form or by any means (including
electronic storage and retrieval or transla-
tion into a foreign language) without prior
agreement and written consent from Agi-
lent Technologies, Inc. as governed by
United States and international copyright
laws.
Manual Part Number
70-9071
Edition
Rev B, May 2013
Agilent Technologies, Inc.
3501 Stevens Creek Blvd.
Santa Clara, CA 95052 USA
Warranty
The material contained in this doc-
ument is provided “as is,” and is
subject to being changed, without
notice, in future editions. Further,
to the maximum extent permitted
by applicable law, Agilent disclaims
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implied, with regard to this manual
and any information contained
herein, including but not limited to
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chantability and fitness for a par-
ticular purpose. Agilent shall not be
liable for errors or for incidental or
consequential damages in connec-
tion with the furnishing, use, or
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Safety Notices
CAUTION
A CAUTION notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly per-
formed or adhered to, could result
in damage to the product or loss
of important data. Do not proceed
beyond a CAUTION notice until
the indicated conditions are fully
understood and met.
WARNING
A WARNING notice denotes a
hazard. It calls attention to an
operating procedure, practice,
or the like that, if not correctly
performed or adhered to, could
result in personal injury or
death. Do not proceed beyond a
WARNING notice until the
indicated conditions are fully
understood and met.

280-DS Operator’s Manual 3
Contents
Figures 5
1Safety 9
Notes, Cautions, and Warnings 10
Warning 10
Caution 10
Note 10
Information Symbols 11
2 Setting Up the 280-DS 13
Introduction 14
Unpacking Your Equipment 15
280-DS Components 16
Vessel Module 16
Instrument Module 17
Magnetic Clip 18
Temperature Probe 18
Setting up the 280-DS 19
Cable Connections 19
Power Cord Connections 19
Requirements and Configuration 20
Environmental Requirements for Use 20
PC Requirements 20
Software Installation 20
Local Security Policy 21
Starting 280-DS Workstation 23

4 280-DS Operator’s Manual
Contents
Starting 280-DS Workstation 23
280-DS Workstation Logon 23
Adding Users to the Application 24
3 Operating the 280-DS 27
280-DS Workstation Logon 28
280-DS Operation 30
Dissolution Apparatus 30
Method Editor 36
Run Method (Method Execution) 41
Running a Method 47
Diagnostics 78
Test Reports 82
Trends 85
Security (21 CFR Part 11 Compliance) 87
Change User 87
Lock Application 87
Audit Trail 88
Permissions 89
Tools 90
4 Troubleshooting and Maintenance 93
Preventive Maintenance 94
Recalibration 94
Troubleshooting 95
5 Service and Warranty 99
Service and Warranty Information 100
Obtaining Warranty and Other Services 100
Index 101

280-DS Operator’s Manual 5
Figures
Figure 1. Vessel Module 16
Figure 2. Instrument Module 17
Figure 3. Magnetic Clip 18
Figure 4. Temperature Probe 18
Figure 5. Logon 23
Figure 6. Local Users and Groups 24
Figure 7. Logon 28
Figure 8. 280-DS Workstation Homescreen 28
Figure 9. Dissolution Apparatuses 31
Figure 10. Identification Information 32
Figure 11. Dissolution Apparatus Shaft Diameters 33
Figure 12. Component Serial Number 34
Figure 13. Reason for Change 35
Figure 14. Test Methods 36
Figure 15. Method Editor General Tab 38
Figure 16. Specification Tab 39
Figure 17. Reason for Change 40
Figure 18. Select Test Method 41
Figure 19. Prepare the Dissolution Apparatus 42
Figure 20. Select the Dissolution Apparatus 43
Figure 21. Select the 280-DS Test Method 44
Figure 22. Stirring Element and Vessel Positions 45
Figure 23. Method Summary Tab 46
Figure 24. Dissolution Apparatus Tab 46
Figure 25. IM Position on Vessel Plate 48
Figure 26. Vessel Plate Level Measurement 49
Figure 27. Proper Hand Position 51
Figure 28. VM Vessel Centering Arm Placement 51
Figure 29. Position for Vessel Module Placement 52

6 280-DS Operator’s Manual
Figures
Figure 30. Diameter Measurement Arm Lever 53
Figure 31. Height Arm Pin 54
Figure 32. Inserting the Vessel Module 55
Figure 33. VM Resting at the Bottom of the Vessel 56
Figure 34. Paddle or Basket Height 57
Figure 35. Paddle / Basket Height 58
Figure 36. Verticality and Centering Measurement 59
Figure 37. Shaft Wobble Test Preparation 60
Figure 38. Shaft Wobble Measurement 61
Figure 39. RPM Detection Magnet Placement 62
Figure 40. RPM Measurement 63
Figure 41. Paddle / Basket Raise 64
Figure 42. Basket Placement for Rim Wobble Test 65
Figure 43. Basket Wobble Measurement 66
Figure 44. Basket Rim Wobble Measurement 67
Figure 45. Completion of the Mechanical Qualification 68
Figure 46. Temperature Probe Placement 69
Figure 47. Bath Temperature Measurement 70
Figure 48. Vessel Temperature Probe Placement 71
Figure 49. Vessel Temperature Measurement 72
Figure 50. IM Placement for Vibration Test 73
Figure 51. Resultant Vibration Display 74
Figure 52. Successful Update MQ Record 75
Figure 53. Unsuccessful Update MQ Record 76
Figure 54. Method Cancelling 77
Figure 55. Current Status Tab 78
Figure 56. Advanced Tab 79
Figure 57. Vibration Tab 80
Figure 58. Module Information Tab 81
Figure 59. Reports 83
Figure 60. Show Result 84
Figure 61. Trend Measurements 85
Figure 62. MQ Measurements Trends 86

280-DS Operator’s Manual 7
Figures
Figure 63. Security Audit Trail 88
Figure 64. Permissions 89
Figure 65. Configuration Dialog Security Tab 90
Figure 66. Configuration Dialog Miscellaneous Tab 91
Figure 67. Database Tools 92

8 280-DS Operator’s Manual
Figures
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9
Agilent Technologies
280-DS
Operator’s Manual
1
Safety
Notes, Cautions, and Warnings 10
The 280-DS Mechanical Qualification System (MQS) has been
designed so that when used properly you have an accurate, fast, flexible,
and safe instrument.
If the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
The 280-DS MQS is operated in conjunction with equipment that uses
aqueous liquids. Unskilled, improper, or careless use of this instrument
can create shock hazards, fire hazards, or other hazards which can cause
death, serious injury to personnel, or severe damage to equipment and
property.
Information on safety practices is provided with your instrument and
operation manuals. Before using your instrument or accessories, you
must thoroughly read these safety practices.
Observe all relevant safety practices at all times.

10 280-DS Operator’s Manual
1Safety
Notes, Cautions, and Warnings
Warning
WARNING
A ‘Warning’ message appears in the manual when failure to observe
instructions or precautions could result in death or injury.
Read all warnings and cautions carefully and observe them at all times.
Caution
CAUTION
A ‘Caution’ message appears in the manual when failure to observe
instructions could result in damage to equipment (Agilent supplied and /
or other associated equipment).
Note
NOTE
A ‘Note’ appears in the manual to give advice or information.

Safety 1
280-DS Operator’s Manual 11
Information Symbols
I Switches main power on
0 Switches main power off
Indicates single-phase alternating current
Indicates the product complies with the
requirements of one or more European Union
(EU) directives.
Indicates specific equipment meets standards of
safety. These products are safe for use in the
workplace for North America.
Indicates that this product must not be disposed
of as unsorted municipal waste.
All Agilent products that are subject to the
WEEE directive shipped after August 13, 2005
are compliant with the WEEE marking
requirements. Such products are marked with the
“crossed out wheelie bin” WEEE symbol in
accordance with European Standard EN 50419.
For more information on collection, reuse, and
recycling systems, please contact your
local/regional waste administration, your local
distributor, or Agilent.
Indicates the product complies with regulatory
compliance requirements of New Zealand and
Australia.

12 280-DS Operator’s Manual
1Safety
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13
Agilent Technologies
280-DS
Operator’s Manual
2
Setting Up the 280-DS
Introduction 14
Unpacking Your Equipment 15
280-DS Components 16
Setting up the 280-DS 19
Requirements and Configuration 20
Starting 280-DS Workstation 23

14 280-DS Operator’s Manual
2 Setting Up the 280-DS
Introduction
The 280-DS Mechanical Qualification System (MQS) is a device which
verifies the physical parameters of a dissolution apparatus. A
Windows®-based software interface captures data from and
communicates, through USB, with two hand-held modules that
comprise the physical part of the device. A hand-held temperature probe
also connects to the instrument module.
The 280-DS is capable of measuring the following on a 1-liter
dissolution apparatus: vessel plate level and vibration, bath or vessel
temperatures, paddle or basket height, spindle shaft centering, spindle
shaft verticality, spindle shaft wobble, spindle shaft speed (RPM),
vessel verticality, and basket rim wobble.
The software interface, which is designed to run on Microsoft Windows
XP Pro and Windows 7 (32-bit and 64-bit), implements controls for the
Electronic Records and Electronic Signatures Rule (21 CFR Part 11)
established by the FDA. The interface also supports the mechanical
qualification tests required by the ASTM, USP, and FDA standards
bodies for a basket and paddle dissolution apparatus.

Setting Up the 280-DS 2
280-DS Operator’s Manual 15
Unpacking Your Equipment
The 280-DS consists of the Instrument Module (IM), Vessel Module
(VM), temperature probe, module intercommunication cable, USB
cable, and RPM magnetic clip, all packaged in a rugged,
compression-resistant case.
A Windows-based PC running the 280-DS software powers and is
connected to the Instrument Module (IM) with a USB cable. The IM
connects to the Vessel Module (VM) through the module
intercommunication cable. The VM is inserted into the vessel and the
Instrument Module is placed on the vessel plate and provides the
temperature probe interface.
Prior to use:
1Remove all system components from the packing material.
2Inspect the equipment and accessories to ensure there has been no
damage during shipment.
3Place the base unit and accessories on a clear, dry, level section of the
bench top close to the dissolution apparatus.

16 280-DS Operator’s Manual
2 Setting Up the 280-DS
280-DS Components
Vessel Module
The Vessel Module (VM) measures rotational speed, basket/shaft
wobble, vessel centering, shaft verticality, vessel verticality, and
basket/paddle height. Once properly positioned, this module provides
reliable, repeatable measurements using innovative sensing technology.
Figure 1 Vessel Module

Setting Up the 280-DS 2
280-DS Operator’s Manual 17
Instrument Module
The 280-DS Instrument Module (IM) is used to record vessel plate level
and vibration while also acting as a hub for the Vessel Module,
temperature probe, and connection to the PC. Quantitative values for
each parameter are recorded and visible in real-time via the software
interface.
Figure 2 Instrument Module

18 280-DS Operator’s Manual
2 Setting Up the 280-DS
Magnetic Clip
The magnetic clip is used in conjunction with the magnetic tachometer
sensor to measure RPM. Each time the magnet passes the sensor, one
rotation is counted.
Figure 3 Magnetic Clip
Temperature Probe
The temperature probe is used to verify the accuracy of the water bath
and vessel temperature probes on the dissolution apparatus. It can also
be used to record individual temperatures prior to beginning a
dissolution test.
Figure 4 Temperature Probe

Setting Up the 280-DS 2
280-DS Operator’s Manual 19
Setting up the 280-DS
Cable Connections
1Connect the Instrument Module of the 280-DS from the USB port on
the Instrument Module to a USB port on the measurement computer.
2Connect the 280-DS Vessel Module to the Instrument Module via the
module intercommunication cable.
3Optionally, connect the measurement computer to the dissolution
apparatus using a 9/25 pin RS-232 cable, a USB-to-RS232 converter,
or run in Offline Mode (“Preparing the Dissolution Apparatus” on
page 42).
Power Cord Connections
1Connect or verify connection of the AC power cord between the
power receptacle on the PC and an AC electrical supply of the
appropriate voltage. If using a laptop, the 280-DS can also be used
when the laptop is on battery power.
2Connect or verify connection of the AC power cord between the
power receptacle on the dissolution apparatus and an AC electrical
supply of the appropriate voltage.
NOTE
The online testing mode provides direct communication between the
dissolution apparatus and the 280-DS Workstation Software. This
feature is only available for Agilent, Varian, or VanKel dissolution
apparatus models.
For PCs without a 9-pin serial port, a USB-to-Serial adapter may be
configured and used to communicate with the dissolution apparatus.
NOTE
Please ensure your computer’s battery is appropriately charged before
using the 280-DS on battery power. The 280-DS draws power from the
computer connected to it and will drain the battery faster than normal.

20 280-DS Operator’s Manual
2 Setting Up the 280-DS
3Turn on the PC and dissolution apparatus.
Requirements and Configuration
Environmental Requirements for Use
•Humidity: max relative humidity 75% non-condensing
•Indoor use only
•Temperature: 10 ºC to 35 ºC
PC Requirements
The software is designed to run on a PC-based platform with the
following minimum specifications:
•1.5 GHz or faster Pentium 4 processor
•1 GB of RAM or more
•16X CD-ROM drive
•1 USB port (minimum)
•10 GB of space on the hard drive
•1280 x 960 at 16M colors (minimum)
•Microsoft Windows XP Professional and Windows 7 (32-bit and
64-bit) operating system
Software Installation
NOTE
If your operating system is Windows 7, you must log on to the computer
as an administrator to set up the software and run it for the first time.
NOTE
If Windows User Access Control (UAC) displays during the installation
process, click Allow to continue installation.